Patient-reported outcomes labeling for products approved by the office of hematology and oncology products of the US Food and Drug Administration (2010-2014)

Carla Janine DeMuro-Romano; Marci Jeanette Clark; Arinesalingam Gnanasakthy; Ari Gnanasakthy; Carla DeMuro Romano; Marci Jeanette Clark; E Haydysch; E Ma; V Bonthapally

Patient-reported outcomes labeling for products approved by the office of hematology and oncology products of the US Food and Drug Administration (2010-2014)

Gnanasakthy, A., DeMuro, C., Clark, M., Haydysch, E., Ma, E., & Bonthapally, V. (2016). Patient-reported outcomes labeling for products approved by the office of hematology and oncology products of the US Food and Drug Administration (2010-2014). Journal of Clinical Oncology, Advance Online Publication(16). Advance online publication. https://doi.org/10.1200/JCO.2015.63.6480

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Abstract

Although symptoms and functional decrements are common among patients with cancer, PRO labeling is rare in the United States, likely because of logistical hurdles and oncology study design. Recent developments within the FDA OHOP to capture PROs in oncology studies for the purpose of product labeling are encouraging.